Consulting
Before the start of sale in the territory of the Russian Federation, all medical devices must undergo state registration with Roszdravnadzor, this is prescribed in Article 38 of the Federal Law of Russia 323 of 11/21/2011.

This applies both to products produced in Russia and to those imported from abroad.
Medical devices and devices (codes 94 4100, 94 4200, 94 4400) and medical equipment (codes 94 5100, 94 5200), medical instruments, dental products and products made of polymeric materials, textiles, rubber are subject to mandatory certification of medical devices in accordance with the Federal Law of Russia and other materials.
Our experts in Moscow will help you to certify products and obtain the necessary certificates and declarations of conformity in accordance with the technical regulations of the Customs Union.

This is a kind of guarantee that the safety of products and their quality is confirmed not only at the Russian, but also at the international level.

Voluntary certification under the EAEU system does not yet exist.
In terms of promoting products on the market, we offer our clients services for the comprehensive development of a brand promotion strategy and tactics, including:

• Analysis of market conditions and competitors;
• Development of a promotion strategy and selection of the necessary tools;
• Formation of pricing policy;
• Formation of distribution geography;
• Search for clients and assistance in concluding contracts.
Aimed at obtaining state registration in the Russian Federation of medical devices.
Example of a contract for the provision of services
"On the fundamentals of protecting the health of citizens in the Russian Federation"
Federal Law of November 21, 2011 No. 323-FZ
Samples of the registration certificate
Contacts
+7 999 595 12 45

info@testsealabs-med.com

Moscow, Borovskoye Shosse, building 2/3

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